New Catheter Delivers RF and Pulsed Field Ablation Through One Device

Johnson & Johnson has announced U.S. Food and Drug Administration (FDA) approval of the Dual Energy THERMOCOOL SMARTTOUCH SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter. Built on the clinically validated THERMOCOOL SMARTTOUCH SF platform, which has been used to treat more than one million patients in the United States, the dual-energy system adds PF capability to a catheter already familiar to physicians. The platform is designed to help physicians tailor energy selection to patient anatomy and case complexity.

The DE STSF platform is integrated with the CARTO ecosystem, combining advanced mapping and imaging with PF Index guidance to support precise energy delivery, measured contact force, and reproducible workflows. By bringing RF and PF capabilities into the same catheter and navigation environment, the system aims to expand intra-procedural versatility and support more predictable procedures.

Following FDA approval, first U.S. procedures with the system are expected to begin this summer as part of a phased commercial rollout. Integration with the CARTO system is intended to help physicians adapt to more complex cases and plan procedures with greater confidence.

“The FDA approval of the Dual Energy THERMOCOOL SMARTTOUCH SF Platform is another important milestone in what has been an incredible pace of innovation for our business. Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson.

“Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals. The Dual Energy THERMOCOOL SMARTTOUCH SF Platform gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the CARTO system can help us adapt our approach for more complex cases and plan procedures with greater confidence,” said Dhanunjaya (DJ) Lakkireddy, M.D., FHRS, MBA, Executive Medical Director, The Kansas City Heart Rhythm Institute.